510(k) · Cleared
ClearedBanks Hydro-Therapy Chair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Keith Products, Inc. · ILM Bath, Sitz, Powered
Cleared on Apr 1, 1996 as substantially equivalent to K914125 (Ferno, 1991) after a 231-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Apr 1, 1996
- Review
- 231 days
- Class
- Class II
- Product code
- ILM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K914125 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK914125 Ferno Ille HI-LO JR. Mobile Whirlpool, Model 403Ferno · 1991
- This deviceK953796 Banks Hydro-Therapy ChairKeith Products, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914125 | Ferno Ille HI-LO JR. Mobile Whirlpool, Model 403 | Ferno | 1991 | — |
| 0 (this device) | K953796 | Banks Hydro-Therapy Chair | Keith Products, Inc. | 1996 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ILM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K914125 | Ferno Ille HI-LO JR. Mobile Whirlpool, Model 403Summary page 1…quivalence to legally marketed predicate device the Ferno-Washington, Inc. “Ferno-llle-Hi-Lo, Jr. ™", The predicate device is a mobile whirlpool bearing Registration No. K914125, Pursuant to 809.92(a)(4), a description of the device is: The Banks Hydro-Therapy Chair provides whirlpool therapy in the home… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K914125.
How does its category compare?
All ILM devicesILM Bath, Sitz, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ILM
FDA has decided no ILM device since 2007.
Median 510(k) review, days · ILM
Too few ILM 510(k)s in any year since 2007 to give a median.
Recalls per year · ILM
No recall names ILM since 2007.
Adverse event reports per year · ILM
5in 2020
MAUDE reports naming product code ILM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 47 |
| 2014 | 0 | — | 0 | 61 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 0 | — | 0 | 20 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
to aid in adding moisture to necrotic areas in order to aid in the debridement of wounds, to aid in the relief of pain and discomfort, to aid in the cleansing of open wounds, and as a form of physical therapy for certain types of pathologies.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K953796 · printed Nov 4, 2026
Cite this page
510(k) Report. “K953796: Banks Hydro-Therapy Chair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953796
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026